MD, MBBS, MD-PhD or equivalent medical degree required
5+ years of experience in Drug Safety & Pharmacovigilance
Strong understanding of US and EU pharmacovigilance regulations
Experience with drug safety in registrational clinical studies
High level of medical competence balanced with industry objectives
Ability to conduct scientific analysis and reasoning
Comprehensive knowledge of drug development processes
Responsibilities
Lead development of pharmacovigilance strategies ensuring compliance with corporate goals
Oversee signal detection activities including monitoring and evaluation of safety information
Conduct Product Safety Committee meetings to assess risk-benefit of compounds
Perform medical safety reviews and causality assessments of safety data
Provide expert safety review input for clinical development documents
Oversee aggregate safety reports and signal evaluation reports
Manage internal safety scientist and operations team
Benefits
Comprehensive health care benefits
Opportunities for professional development
Collaborative and inclusive work environment
Flexible work arrangements
Engagement in cutting-edge biopharmaceutical research
Full Job Description
Summary of Position:
The Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.
Position Responsibilities:
Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals.
Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information.
Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee.
Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
Oversight of aggregate reports and signal evaluation reports for assigned projects.
Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable.
Oversee and collaborate with internal safety scientists within TA
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws.
Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.)
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
Support process improvement and functional training at departmental & company level
Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work.
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations
Candidate Requirements:
MD or MBBS or MD-PhD or equivalent medical degree
5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
Strong understanding of pharmacovigilance regulations in the US and EU.
Experience in supporting drug safety activities in registrational clinical studies
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
Demonstrated skills in scientific analysis and reasoning.
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
Strong track record of delivering results through effective team and peer leadership in matrix
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
$280,000 - $420,000 a year
About Scholar Rock Holding Corporation
Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company that focuses on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company's proprietary platform technology is based on the use of growth factor-binding proteins to selectively inhibit the activation of these signaling pathways in a variety of tissues. Scholar Rock's lead product candidate, SRK-015, is a highly specific inhibitor of the activation of the growth factor myostatin, which is involved in the regulation of muscle mass. The company is headquartered in Cambridge, Massachusetts and was founded in 2012.
